Standard Svensk standard · SS-EN ISO 11138-2:2017

Sterilisering av medicintekniska produkter - Biologiska indikatorer - Del 2: Biologiska indikatorer för steriliseringsprocesser med etylenoxid (ISO 11138-2:2017)

Status: Gällande

Omfattning
ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for work place safety.

Ämnesområden

Desinficeringsmedel och antiseptika


Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

Internationell titel: Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)

Artikelnummer: STD-8025810

Utgåva: 3

Fastställd: 2017-04-05

Antal sidor: 24

Ersätter: SS-EN ISO 11138-2:2009